Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017225
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2001-06-06
Brief Title:
Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
Sponsor:
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells Combining these therapies may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma
Detailed Description:
OBJECTIVES
Determine the frequency of spontaneous remission in pediatric patients with localized neuroblastoma
Determine the course of regression in patients with spontaneous remission
Determine the event-free survival rate of patients with high-risk neuroblastoma treated with maintenance chemotherapy OR consolidation chemotherapy followed by autologous stem cell rescue
Determine if a correlation exists between long-term overall survival and catecholamine response in these high-risk patients
Determine if a correlation exists between cytotoxic and conditioning chemotherapies in terms of bone marrow toxicity in these high-risk patients
OUTLINE This is a multicenter study Patients are stratified according to risk low vs standard vs high
Observation stratum low risk Patients undergo surgical biopsy followed by observation for 6-12 months Patients may also undergo second-look surgery Patients with tumor regression receive no further therapy Patients with disease progression or no tumor regression receive standard-risk chemotherapy as in the standard-risk stratum
Standard-risk stratum Patients undergo surgical biopsy Patients at least 6 months of age receive 1 course of chemotherapy comprising cisplatin IV and etoposide IV continuously on days 1-4 and vindesine IV over 1 hour on day 1 Patients then receive 1 course of chemotherapy comprising vincristine IV over 1 hour on days 1 and 8 dacarbazine IV over 1 hour on days 1-5 ifosfamide IV continuously on days 1-5 and doxorubicin IV over 4 hours on days 6 and 7
Patients under 6 months of age receive doxorubicin IV over 30 minutes and vincristine IV on days 1 3 and 5 and cyclophosphamide IV over 5 minutes on days 1-7 Treatment repeats every 3 weeks for 2 courses in the absence of unacceptable toxicity
After chemotherapy patients may undergo second-look surgery followed by 2 additional courses of chemotherapy as above Patients with complete response or very good partial response receive no further therapy Patients with partial response minimal response no response or progressive disease undergo local radiotherapy daily 5 days a week for approximately 6 weeks Patients with no response after radiotherapy may then receive therapy as in the high-risk stratum
High-risk stratum Patients undergo surgical biopsy Patients at least 6 months of age receive induction chemotherapy comprising cisplatin etoposide and vindesine as in the standard-risk stratum combined with filgrastim G-CSF subcutaneously SC daily beginning on day 8 and continuing until blood counts recover Patients also receive alternating courses of vincristine dacarbazine ifosfamide and doxorubicin as in the standard-risk stratum combined with G-CSF SC daily beginning on day 9 and continuing until blood counts recover Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity
Patients under 6 months of age receive 2 courses of induction chemotherapy as in the standard-risk stratum followed by 4 courses of alternating chemotherapy as above
Patients may also undergo second-look surgery
Patients then receive consolidation chemotherapy comprising melphalan IV over 30 minutes on days -8 to -5 etoposide IV over 4 hours on day -4 and carboplatin IV over 1 hour on days -4 to -2 Patients undergo autologous stem cell transplantation ASCT on day 0 Patients also receive G-CSF SC or IV over 2 hours daily beginning on day 0 Patients may then undergo radiotherapy daily 5 days a week for 6 weeks
Patients who were diagnosed less than 1 year ago and who do not demonstrate MYCN amplication receive maintenance chemotherapy comprising oral cyclophosphamide on days 1-8 instead of consolidation chemotherapy and ASCT as above Treatment repeats every 3 weeks for 4 courses
Beginning 4-6 weeks after transplantation or 4 weeks after initiation of the last course of maintenance chemotherapy all patients receive consolidation therapy with oral tretinoin 3 times daily on days 1-14 Treatment repeats every 28 days for 6 courses followed by a 3-month rest Patients then receive 3 additional courses
Patients are followed at 6 weeks every 3 months for 5 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 130 patients 50 in high-risk stratum 15 in standard-risk stratum and 65 in observation stratum will be accrued for this study within 1 year
Determine the frequency of spontaneous remission in pediatric patients with localized neuroblastoma
Determine the course of regression in patients with spontaneous remission
Determine the event-free survival rate of patients with high-risk neuroblastoma treated with maintenance chemotherapy OR consolidation chemotherapy followed by autologous stem cell rescue
Determine if a correlation exists between long-term overall survival and catecholamine response in these high-risk patients
Determine if a correlation exists between cytotoxic and conditioning chemotherapies in terms of bone marrow toxicity in these high-risk patients
OUTLINE This is a multicenter study Patients are stratified according to risk low vs standard vs high
Observation stratum low risk Patients undergo surgical biopsy followed by observation for 6-12 months Patients may also undergo second-look surgery Patients with tumor regression receive no further therapy Patients with disease progression or no tumor regression receive standard-risk chemotherapy as in the standard-risk stratum
Standard-risk stratum Patients undergo surgical biopsy Patients at least 6 months of age receive 1 course of chemotherapy comprising cisplatin IV and etoposide IV continuously on days 1-4 and vindesine IV over 1 hour on day 1 Patients then receive 1 course of chemotherapy comprising vincristine IV over 1 hour on days 1 and 8 dacarbazine IV over 1 hour on days 1-5 ifosfamide IV continuously on days 1-5 and doxorubicin IV over 4 hours on days 6 and 7
Patients under 6 months of age receive doxorubicin IV over 30 minutes and vincristine IV on days 1 3 and 5 and cyclophosphamide IV over 5 minutes on days 1-7 Treatment repeats every 3 weeks for 2 courses in the absence of unacceptable toxicity
After chemotherapy patients may undergo second-look surgery followed by 2 additional courses of chemotherapy as above Patients with complete response or very good partial response receive no further therapy Patients with partial response minimal response no response or progressive disease undergo local radiotherapy daily 5 days a week for approximately 6 weeks Patients with no response after radiotherapy may then receive therapy as in the high-risk stratum
High-risk stratum Patients undergo surgical biopsy Patients at least 6 months of age receive induction chemotherapy comprising cisplatin etoposide and vindesine as in the standard-risk stratum combined with filgrastim G-CSF subcutaneously SC daily beginning on day 8 and continuing until blood counts recover Patients also receive alternating courses of vincristine dacarbazine ifosfamide and doxorubicin as in the standard-risk stratum combined with G-CSF SC daily beginning on day 9 and continuing until blood counts recover Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity
Patients under 6 months of age receive 2 courses of induction chemotherapy as in the standard-risk stratum followed by 4 courses of alternating chemotherapy as above
Patients may also undergo second-look surgery
Patients then receive consolidation chemotherapy comprising melphalan IV over 30 minutes on days -8 to -5 etoposide IV over 4 hours on day -4 and carboplatin IV over 1 hour on days -4 to -2 Patients undergo autologous stem cell transplantation ASCT on day 0 Patients also receive G-CSF SC or IV over 2 hours daily beginning on day 0 Patients may then undergo radiotherapy daily 5 days a week for 6 weeks
Patients who were diagnosed less than 1 year ago and who do not demonstrate MYCN amplication receive maintenance chemotherapy comprising oral cyclophosphamide on days 1-8 instead of consolidation chemotherapy and ASCT as above Treatment repeats every 3 weeks for 4 courses
Beginning 4-6 weeks after transplantation or 4 weeks after initiation of the last course of maintenance chemotherapy all patients receive consolidation therapy with oral tretinoin 3 times daily on days 1-14 Treatment repeats every 28 days for 6 courses followed by a 3-month rest Patients then receive 3 additional courses
Patients are followed at 6 weeks every 3 months for 5 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 130 patients 50 in high-risk stratum 15 in standard-risk stratum and 65 in observation stratum will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068664 | REGISTRY | None | None |
| EU-20102 | None | None | None |
| GER-GPOH-NB97 | Registry Identifier | PDQ Physician Data Query | None |